FDA 510(k) Application Details - K043463

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K043463
Device Name	Oximeter
Applicant	ENVITEC-WISMAR GMBH S65 W35739 PIPER RD EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN GORSKI Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2004
Decision Date	02/11/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review